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Electrical Status Epilepticus in Sleep research study

What is the primary objective of this study?

Electrical status epilepticus in sleep (ESES) is a pattern of abnormal discharges in the
electroencephalogram (EEG). Children who have this pattern present seizures and
neuropsychological regression. There are no studies that systematically evaluate the response
of abnormal discharges in the EEG, seizures and neuropsychological regression to different
antiepileptic treatments. Therefore, treatment strategies in ESES are not based on scientific
evidence. High-dose benzodiazepines such as diazepam (valium) have been reported to improve
the severe EEG abnormalities of patients with ESES in the short-term. But the long-term
response of seizures and neuropsychological regression has not been systematically studied.
Clobazam is a benzodiazepine derivative with antiepileptic properties. The pharmacologic
properties of clobazam make of this drug a particularly useful option in ESES: in patients
with ESES the alpha-2 subunit of the GABA receptor is preferentially up-regulated and
clobazam may have a higher affinity for this particular subunit, so investigators expect a
higher effect of this drug on ESES patients than with other benzodiazepines (Loddenkemper et
al, in preparation). The aim of our study is to objectively evaluate the response to clobazam
treatment of neuropsychological deficits, seizures and abnormal discharges in the EEG in
patients with ESES. Clobazam treatment is used in routine clinical practice and investigators
will objectively quantify its effect.
Our working hypothesis is that high-dose clobazam treatment may control the abnormal
epileptiform discharges in the EEG in patients with ESES. The reduction in abnormal
epileptiform discharges may lead to an improvement in neuropsychological deficits and
seizures. The predicted improvement in seizures and neuropsychological function would lead to
a better quality of life in these patients.

Who is eligible to participate?

Inclusion Criteria:
- A change in treatment regimen is required because of very active epileptiform activity
during sleep and neuropsychological regression. This means that only patients with
very active epileptiform activity and, therefore, with a need for a change in
treatment regimen as clinically indicated will be potentially eligible. Additionally,
a prior clinical decision to use clobazam should have been made by the primary
epileptologist in order to participate in the study.
- Availability for clinical, neuropsychological and EEG follow-up.
Exclusion Criteria:
- Electro-clinical evolution that does not require a change in medication regimen or
changes in medication regimen that do not include clobazam.

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:ESES treated with clobazamThe patients that will participate in the protocol will be those that are administered for clinical reasons oral clobazam.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

ESES treated with clobazamThe patients that will participate in the protocol will be those that are administered for clinical reasons oral clobazam.

Discuss Diazepam

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